IN THE HIGH COURT OF SOUTH AFRICA (TRANSVAAL PROVINCIAL DIVISION) CASE NO: 4183/98 In the matter between THE PHARMACEUTICAL MANUFACTURERS' ASSOCIATION OF SOUTH AFRICA First Applicant ALCON LABORATORIES (S.A.) (PROPRIETARY) LIMITED Second Applicant BAYER (PROPRIETARY) LIMITED Third Applicant BRISTOL-MYERS SQUIBB (PROPRIETARY) LIMITED Fourth Applicant BYK MADAUS (PROPRIETARY) LIMITED Fifth Applicant ELI LILLY (SOUTH AFRICA) (PROPRIETARY) LIMITED Sixth Applicant GLAXO WELLCOME (SOUTH AFRICA) (PROPRIETARY) LIMITED Seventh Applicant HOECHST MARION ROUSSEL LIMITED Eighth Applicant INGELHEIM PHARMACEUTICALS (PROPRIETARY) LIMITED Ninth Applicant JANSSEN-CILAG PHARMACEUTICA (PROPRIETARY) LIMITED Tenth Applicant KNOLL PHARMACEUTICALS SOUTH AFRICA (PROPRIETARY) LIMITED Eleventh Applicant LUNDBECK SOUTH AFRICA (PROPRIETARY) LIMITED Twelfth Applicant MERCK (PROPRIETARY) LIMITED Thirteenth Applicant MSD (PROPRIETARY) LIMITED Fourteenth Applicant NOVARTIS SOUTH AFRICA (PROPRIETARY) LIMITED Fifteenth Applicant NOVO NORDISK (PROPRIETARY) LIMITED Sixteenth Applicant PHARMACIA & UPJOHN (PROPRIETARY) LIMITED Seventeenth Applicant RHONE-POULENC RORER SOUTH AFRICA (PROPRIETARY) LIMITED Eighteenth Applicant ROCHE PRODUCTS (PROPRIETARY) LIMITED Nineteenth Applicant SCHERING (PROPRIETARY) LIMITED Twentieth Applicant SCHERING-PLOUGH (PROPRIETARY) LIMITED Twenty-First Applicant S.A. SCIENTIFIC PHARMACEUTICALS (PROPRIETARY) LIMITED Twenty-Second Applicant SMITHKLINE BEECHAM PHARMACEUTICALS (PROPRIETARY) LIMITED Twenty-Third Applicant UNIVERSAL PHARMACEUTICALS (PROPRIETARY) LIMITED Twenty-Fourth Applicant WYETH (PROPRIETARY) LIMITED Twenty-Fifth Applicant XIXIA PHARMACEUTICALS (PROPRIETARY) LIMITED Twenty-Sixth Applicant ZENECA SOUTH AFRICA (PROPRIETARY) LIMITED Twenty-Seventh Applicant BAYER AG Twenty-Eighth Applicant BOEHRINGER-INGELHEIM INTERNATIONAL GmbH Twenty-Ninth Applicant BOEHRINGER-INGELHEIM KG Thirtieth Applicant BRISTOL-MYERS SQUIBB COMPANY Thirty-First Applicant BYK GULDEN LOMBERG CHEMISCHE FABRIK GmbH Thirty-Second Applicant DR. KARL THOMAE GmbH Thirty-Third Applicant ELI LILLY AND COMPANY Thirty-Fourth Applicant F. HOFFMANN-LA ROCHE AG Thirty-Fifth Applicant MERCK KGaA Thirty-Sixth Applicant MERCK & CO., INC. Thirty-Seventh Applicant RHONE-POULENC RORER S.A. Thirty-Eighth Applicant SMITHKLINE BEECHAM plc Thirty-Ninth Applicant OLIVER CORNISH Fortieth Applicant and THE PRESIDENT OF THE REPUBLIC OF SOUTH AFRICA, THE HONOURABLE MR N.R. MANDELA N.O. First Respondent THE SPEAKER OF THE NATIONAL ASSEMBLY, THE HONOURABLE DR. F.N. GINWALA N.O. Second Respondent THE CHAIRPERSON OF THE NATIONAL COUNCIL OF PROVINCES, THE HONOURABLE MR M.G.P. LEKOTA, N.O. Third Respondent THE MINISTER OF HEALTH, THE HONOURABLE DR. N.C. DLAMINI ZUMA N.O. Fourth Respondent THE CHAIRPERSON OF THE PORTFOLIO COMMITTEE ON HEALTH (NATIONAL ASSEMBLY), THE HONOURABLE DR. A.S. NKOMO N.O. Fifth Respondent THE CHAIRPERSON OF THE SELECT COMMITTEE ON SOCIAL SERVICES (COUNCIL OF PROVINCES), THE HONOURABLE DR. S.C. CWELE N.O. Sixth Respondent THE CHAIRPERSON OF THE MEDICINES CONTROL COUNCIL, PROFESSOR P.I. FOLB N.O. Seventh Respondent THE PREMIER OF THE GAUTENG PROVINCE, THE HONOURABLE MR. M. MOTSHEKGA N.O. Eighth Respondent THE MEMBER OF THE EXECUTIVE COMMITTEE FOR HEALTH OF THE GAUTENG PROVINCE, THE HONOURABLE MR. A. MASONDO N.O. Ninth Respondent THE REGISTRAR OF PATENTS, MR. C. BURTON-DURHAM N.O. Tenth Respondent In the application to be admitted as an amicus curiae TREATMENT ACTION CAMPAIGN Amicus Applicant REPLYING AFFIDAVIT I, the undersigned THEODORA STEELE do hereby make oath and say that: 1. I am an Executive Member of the Amicus Applicant and I am duly authorised to act on its behalf in this application. I have also been a trade union leader for more than seventeen years. Currently, I hold the position of Campaigns Co-ordinator of the largest labour federation in the country - the Congress of South African Trade Unions (COSATU), which has 1,8 million members. I previously deposed to the Founding Affidavit in this application. 2. The facts contained herein are to the best of my knowledge true and correct and are, unless otherwise stated or indicated by the context, within my personal knowledge. 3. In this affidavit, all references to the founding documents and annexures refer to the application to be admitted as amicus curiae, unless otherwise indicated. 4. I have read the answering affidavit and annexures of the Applicants in this matter and the reply of the Amicus Applicant is set out below. The answers provided by Mirreyena Deeb do not address the issues of substance raised in the application by the Treatment Action Campaign (TAC) to be admitted as amicus curiae in the above matter. Therefore, responding to every allegation of the applicants answering affidavit would be burdensome to the Court. However, no inference regarding the veracity or otherwise of all Deeb's answers and allegations should be drawn from the Amicus Applicant's reluctance to burden the Court with tangential matters. 5. The Amicus Applicant takes note of paragraph 3 of the answering affidavit except for the last sentence that couches constitutional rights of people with HIV/AIDS in inappropriate sentiment. The issues at stake in the main application are not "narrow" and their adjudication is pertinent to the issues canvassed by the Amicus Applicant. LOCUS STANDI 6. Paragraph 5 of the answering affidavit is an attempt by the applicants to limit the constitutional right of the Amicus Applicant to be heard. They select a single ground that the Amicus Applicant advances, namely the fact that many people with HIV fear acting in their own name, to question its standing as an "organisation of substance". The fact that the Amicus Applicant has members who rely on their constitutionally protected right to privacy as protection from discrimination should be obvious. I am advised by my attorneys that this Honourable Court has in fact ruled on the protection of the identity of a litigant with HIV/AIDS. See C v Minister of Correctional Services 1996 (4) SA 292 (T) 7. People living with HIV/AIDS constitute a vulnerable, often marginalised minority, subject to stigma, systemic disadvantage, unfair discrimination and because their rights, in particular the right of access to health care, are infringed on a daily basis, have a direct and independent interest in the outcome of the main application. Reference will be made to a decision of the Constitutional Court which recognises the nature and extent of discrimination against people living with HIV/AIDS. 8. The Amicus Applicant is an under-resourced voluntary association of people with HIV/AIDS, their friends, families, health care-givers supported by organisations such as trade unions, churches and international bodies (see paragraphs 4-10 of the Amicus Applicant's founding affidavit). However, lack of resources should not be misconstrued for a lack of substance, whatever may be intended by this snide insinuation. 9. The TAC National Executive Committee is constituted on the basis of Provincial and National Meetings and sectoral representatives - unions, non-governmental organisations and AIDS service organisations. The following individuals constitute the national executive of the TAC: Zackie Achmat (Chairperson); Sharon Ekambaram (Acting Director, AIDS Consortium); Nathan Geffen (TAC volunteer); Mark Heywood (Deputy Chairperson, Head: AIDS Law Project); Mazibuko Jara (SACP media officer); Neli Khuzwayo (volunteer); Moshe More (SA National NGO coalition); Promise Mthembu (person living with HIV); Joyce Phekane (COSATU Executive); Theodora Steele (COSATU); Dinesh Singh (volunteer). 10. Since the commencement of its application to be admitted as amicus curiae campaign work on this matter has proceeded. On 12th February 2001, the TAC organised an inter-faith service and march for treatment access and to draw public attention to the importance of these proceedings in Cape Town. More than 1,500 people were led by the Anglican Archbishop Njongongkulu Ndungane. TAC chairperson, Zackie Achmat, presented a memorandum to parliament that read in part: TAC Supports the Medicines and Related Substances Control Amendment Act 90 of 1997 In the first democratic parliament, former President Mandela and former Health Minister Dr. Nkosazana Zuma created a legal framework to make health-care and medicines more accessible. The Medicines and Related Substances Control Amendment Act, No. 90 of 1997 is one such law. Since then, the law has been rendered ineffective through litigation while more than 400 000 people with HIV/AIDS in South Africa have died, the majority because they could not afford access to anti-retroviral treatment. We condemn the Pharmaceutical Manufacturers Association and the pharmaceutical companies who, through litigation, have delayed the implementation of this law. Each day that this law is delayed, they protect their exorbitant profits at the expense of the lives of people with HIV/AIDS. The Treatment Action Campaign and its civil society partners will organise mass action against these companies. (AA25) 11. Between 17th and 26th February 2001, the Amicus Applicant held three provincial conferences. It also aims to hold a national Treatment Congress from 18th -21st March 2001. On 17th February 2001, I attended the Gauteng Provincial Conference of TAC where more than 250 people with HIV/AIDS, health care workers, women's organisations, trade unions and members of many civil society bodies participated as delegates. On 24th February 2001, TAC deputy-chairperson, Mark Heywood, attended the TAC KwaZulu-Natal Provincial Conference where more than 120 delegates joined the conference from a similar range of organisations and a diverse number of individual delegates. On 24th & 25th February, TAC chairperson, Zackie Achmat, attended the TAC Western Cape Provincial Conference where more than 300 registered delegates participated with a similar social composition as I indicated for Gauteng. 12. The answering affidavit consciously ignores the affidavits given under oath and affirmation of health care professionals with direct legal and ethical interests in these proceedings such as Dr. Hermann Reuter (AA9) who joined the TAC during 1999. 13. The answering affidavit also ignores the affidavits of people living with HIV/AIDS and their families (AA11-22) who are office bearers or members of the TAC. These individuals have combined in an organisation (TAC) to promote the constitutional rights to life, dignity, equality and health care access in their own right and in the broader public interest. They include: Zackie Achmat (AA11); Nomfundo Dubula (AA12); Mkhanyiseli Mpalali (AA13); Siphokazi Mthati (AA14); Helen Makebesana (AA15); Ntombozuko Khwaza (AA16); Thandeka Mantshi (AA17); Rose Feni (AA18); Patricia Dove (AA19); Vernon Ogle (AA20); Charlotte Mohapi (AA21) and Judith Ogle (AA22). Should the above Honourable Court request further affidavits or evidence of the membership or nature of the Amicus Applicant that indicates its substance, the organisation will provide such evidence. 14. From the above affidavits, it is clear that many members of the Amicus Applicant are unemployed and desperately poor. Others have an income but nothing that compares to the material resources of the applicants in this matter. On their own version, the drug company applicants' sales income in South Africa exceeds R10 billion per annum (See paragraph 2.45 of Deeb's Founding Affidavit). According to the prestigious magazine The Economist: "This $350 billion industry is growing by 10% a year and enjoys margins of over 35%. Over 60% of profits are made in the United States. With the world ageing and the human genome mapped, prospects are very healthy." (The World in 2001 pages 110 - The Economist) 15. As a trade union leader, I am aware that South African courts have held that workers' rights to collective bargaining are based on the recognition that employers enjoy greater social and economic power than individual workers. As a TAC member, I regard the situation of the TAC in its relationship to the pharmaceutical companies as analogous to the power relationships between employer and employee. Only through combining as individuals, winning public support and the solidarity of civil society bodies can an organisation such as the Amicus Applicant influence policy. 16. The TAC and its members have fewer social and economic resources at their disposal than both the applicants and the respondents in this matter. For instance, in the United States of America, the Pharmaceutical Manufacturers are reported to employ 297 lobbyists in Washington alone or one lobbyist for every two members of Congress. (AA26 See article in The Guardian "Industry that stalks the US corridors of power" 13th February 2001). THE CONDONATION APPLICATION 17. It is appropriate to deal with the allegations of the applicant regarding the condonation application at this point. 18. The Amicus Applicant does not dispute that the proceedings in this matter commenced in February 1998 as stated in paragraph 6 of the answering affidavit. Of course, this was ten months before the TAC came into existence. But, since the inception of this organisation, the Amicus Applicant has shown an urgency and desire to solve this dispute on the basis of the right to life, dignity, equality and access to health care. From the papers, it is abundantly clear that this urgency is unmatched in enthusiasm by the applicants or even the respondents in the main application (see paragraphs 23 to 27 of the Founding Affidavit of the Amicus Applicant). The allegation of dilatoriness on the part of the Amicus Applicant is unsubstantiated and wrong. 19. Apart from the fact of the Amicus Applicant's understanding and assumptions regarding the so-called suspension of these proceedings against the respondents, the issues canvassed by Deeb in paragraphs 7-10 of her answer are immaterial to the condonation application before the Court. 20. The TAC was well aware that the matter was ongoing (and considered it to be such even during the period of "suspension"), hence its continuing engagements with the parties referred to in detail in its Application for admission as amicus curiae. The newspaper articles referred to by the Applicant do not take the matter further as they do not indicate a date for the hearing. 21. The Amicus Applicant does not deny the fact that the "suspension" may have been lifted. But, the Amicus Applicant only became aware that the matter was set down for a hearing on 11 January 2001. 22. In fact, the history of the "suspension" bears out the Amicus Applicant's version of events. The drug company applicants were never interested in a legal framework that makes medicines affordable, accessible and protects legitimate patent rights. They insist on a patent regime that is legally cumbersome to governments and people and that will maximise profits. 23. In paragraphs 9.9 to 9.11 of the answering affidavit, the reason for the "suspension" becomes clear. After learning that the US government, under pressure from its own citizens and the Amicus Applicant, was abandoning its narrow defence of the multinational drug industry, the applicants "suspended" their legal proceedings with indecent haste because they had lost the support of the most powerful government in the world. 24. The applicant's answering affidavit (paragraph 12) cannot avoid admitting that they were "engaged" by the Amicus Applicants through third parties to enter negotiations, or, a mediation process (see Founding Affidavit paragraph 25.16). Their suggestion that a process that had been prepared months in advance was cancelled two days prior to the meeting because Judge Edwin Cameron was to co-chair this event with Dr. John Matjila does not bear scrutiny. The applicants had the opportunity to raise their concerns regarding this matter at the outset, or soon thereafter, not two days before the event and after several months of preparation. In any event, Judge Cameron's participation would have allowed the applicant's to make an application for recusal should this matter have been placed before him. 25. Paragraph 13 of the applicant's response is confusing and contradictory. I am informed by Mr Heywood that he did not receive a copy of Mrs Deeb's "report" and that a date for the commencement of the Court case was not reported to the seminar - despite the fact that the First Applicant had caused it to be set down almost one month earlier, and therefore ought to have been able to provide the seminar with concrete and relevant information, as opposed to allegedly mooting the date of March 2001 as the "possible hearing date". I also draw the attention of this Honourable Court to the fact that Annexure "D19" which purports to be the report given by the First Applicant to the Human Rights Commission on December 1st 2000 is in fact dated "October 2000." Between October 2000 and December 1st there were clearly material developments. Why the First applicant chose to shade them in ambiguity is unclear. The Confirmatory Affidavit of Mark Heywood is annexed hereto as AA27. 26. Paragraph 14 of the drug company applicant's answering affidavit is an unsavoury tactic used to cast aspersion on the intentions of the amicus application. Court papers are public documents and are available for perusal by any member of the public. The Amicus Applicant therefore does not understand the Applicant 's references to how copies were obtained. In August 1999 the AIDS Law Project (ALP), the attorneys of record for the matter, instructed their Pretoria correspondent to obtain copies of the court record in this matter. A copy of the invoice is annexed as AA28. The court file was incomplete. 27. In January 2001, upon hearing that the matter had been set down, the ALP immediately contacted the State Attorney to obtain copies of the latest pleadings as they were not in the court file. 28. Paragraph 2.2 of the TAC Constitution states clearly: "TAC will remain independent of government and the pharmaceutical industry" (AA2). Should this Honourable Court request it, I will have no hesitation in placing before this Court a record of events in relation to the Amicus Applicant's dispute with the Respondents regarding the issue of mother-to-child transmission of HIV. This is an issue that remains unresolved between the Amicus Applicant and the respondent. I also attach copies of three recent posters issued by the Amicus Applicant that address demands to both the applicants and the Government of South Africa. They are attached as AA29, 30 and 31. The drug company applicant may consider this part of our strategy of "prayer and insult" to be offensive. However, the Amicus Applicant believes that it is fair comment based on our right to freedom of expression. 29. In this Court matter, the Amicus Applicant has no doubt that the government's purpose to make medicines more affordable to all people is legitimate and rational. This action will benefit members of the Amicus Applicant, provide increased access to treatment for people with HIV/AIDS and other chronic illnesses, as well as allow them to live a longer, healthier and productive lives. This will not undermine our independence in any way. 30. From the perspective of its members' rights to life, dignity, and access to health care, as well as the best interests of children with HIV/AIDS, the Amicus Applicants believes that the only real basis for the establishment of trust between it and the Respondents will be the implementation of a treatment plan for people with HIV/AIDS including the provision of anti-retroviral treatment. The suggestion of the applicants of a conspiracy between the Amicus Applicant and the Respondents is simply spurious. PREJUDICE TO THE APPLICANTS 31. The Amicus Applicant is not yet a party to these proceedings. Accordingly it would be premature for it to serve and file heads of argument at this stage. Should the Amicus Applicant be admitted to the proceedings it will immediately make heads of argument available to this Honourable Court and to the parties. If the Amicus Applicant is admitted, the Applicants will accordingly be in possession of the Amicus Applicant's heads of argument more than a week in advance of the time at which the Applicants present their oral submissions in reply. 32. Furthermore, I have been advised by my attorneys of record that counsel for the Amicus Applicant will require no more than two hours to present any oral submissions that this Honourable Court may permit him to present, and that Counsel for the Respondents has indicated that he would be willing to grant the Amicus Applicant this amount of time from his provisional allocation of time for oral argument. 33. In the circumstances, I respectfully submit that the Applicants will suffer no prejudice if the Amicus Applicant is admitted to these proceedings. THE RELEVANCE OF THE GROUNDS ON WHICH THE AMICUS APPLICANT INTENDS TO INTERVENE 34. In paragraph 22 the drug company applicant asserts that the basic contention of the Amicus Applicant's submission would appear to be that the Amendment Act creates a legal basis for access to cheaper medicines. She then asserts that it is not an issue before this Honourable Court to determine whether medicines are expensive or cheap, but only to determine whether or not certain constitutional rights of the applicants have been infringed. The Amicus Applicant respectfully begs to differ. 35. As set out in the Amicus Applicant's Founding affidavit (paragraphs 58 to 71), I believe that to reach a sound judgment on the issues, this Honourable Court must consider the context, objectives, rationale and proportionality of the sections in the Amendment Act of interest to the Amicus Applicant. It has to consider the constitutional rights that the Respondent is under a duty to protect, promote and progressively realise. 36. It would also benefit this Honourable Court to hear argument from the Amicus Applicant on whether there exists a hierarchy of duties created by the various international treaties which the Respondent has ratified. Then, if the Court finds that the rights of the applicants have been infringed, it will be in a sound position to determine whether such limitation is justifiable in an open and democratic society. The Amicus Applicant believes that it has a unique perspective to offer the Honourable Court on these questions (see paragraphs 85 to 98 of the Founding Affidavit). 37. Finally, contrary to the assertions of the drug company applicant, the question of the affordability of medicines is a recurrent theme that reverberates through the affidavits of both the applicant and the respondent. For example, the Fourth Respondent asserts in his Answering Affidavit at paragraph 17: [t]hat the Amendment Act contains provisions which are vitally necessary to ensure that the public receive the benefit of cheaper and safer medicines. I believe that the applicants are not in favour of the Amended Act as it will drastically affect their profit margins. at paragraph 57 that: [w]hile patent protection is necessary, there is a great need to prevent patent holders from abusing the exclusive rights for their own benefit and to the detriment of the public, because medicine should not be considered to be an ordinary commodity. At paragraph 73 (f) that: It is incumbent on the state to find means within the framework of the Constitution to firstly keep those prices as affordable as possible, and secondly to achieve a greater goal, namely to make health care of good quality and quantity accessible to all. At paragraph 77( c) that: The government is under a constitutional obligation to provide health care to all South African citizens and in order to attain this objective, cost containment measures are inevitably necessary. In recent times patients have been denied vital treatment because such treatment could not be afforded by the State. Such a situation is clearly untenable and gives rise to serious moral dilemmas which the Government, in the spirit of creating a society where the respect for human dignity is paramount, has to avoid. 38. The Amicus Applicant re-iterates that it seeks permission to bring before this Honourable Court legal argument that will supplement that of the Respondent from the perspective of South African citizens denied access to medicines because of their cost. 39. In conclusion, we draw the attention of this Court to a confirmation from the mouth of the drug company applicant that the question of access to HIV/AIDS medicines has a particular relevance and relationship to the objectives of the Amended Act. In annexure "D 11", attached and drafted by Deeb, the PMA concedes the inextricable connection between the draft legislation and the need "to increase access to medicine for all South Africans - particularly with regard to HIV/AIDS." These issues were linked by the drug company applicants in their "suspension" negotiations. The negotiations failed because of continued objections from the drug company applicants to the principle that the South African government has a constitutional right and a duty to create a modern legal framework that balances patent rights and health care access. In fact, the drug company applicants admit that "a stated objective of the Amendment Act was to reduce what were claimed to be excessive pharmaceutical costs [sic read prices] in South Africa". 40. The legal framework is necessary to create sustainable access to essential medicines that does not depend on the fickle acts of charity or fragile partnerships offer by these companies. The Amicus Applicant submits that its arguments on the neccessity for the legislation provides a unique perspective on an epidemic that will change the lives of all people in Africa for generations. 41. The TAC seeks relief from the above Honourable Court as set out in the original Notice of Motion for condonation and to be admitted as amicus curiae in the above matter. ________________________ DEPONENT SIGNED AND SWORN TO BEFORE ME AT JOHANNESBURG ON THIS THE 16TH DAY OF FEBRUARY 2001, THE DEPONENT HAVING ACKNOWLEDGED THAT SHE KNOWS AND UNDERSTANDS THE CONTENTS OF THIS AFFIDAVIT, THAT SHE HAS NO OBJECTION TO TAKING THE PRESCRIBED OATH AND THAT SHE CONSIDERS THE SAME AS BINDING ON HER CONSCIENCE. ________________________ COMMISSIONER OF OATHS DATED at JOHANNESBURG on this the 1st day of March 2001. __________________________ APPLICANT'S ATTORNEYS AIDS LAW PROJECT Centre for Applied Legal Studies 1ST Floor, D J du Plessis Centre West Campus University of the Witwatersrand Cnr Jan Smuts & Yale Road Braamfontein Tel: (011) 717-8637 Fax: (011) 403-2341 Ref: A Kleinsmidt / M Heywood TO: The Registrar The Above Honourable Court PRETORIA AND TO: ___________________________ APPLICANTS' ATTORNEY D M Kisch Inc. 66 Wierda Road East Wierda Valley Tel: 884-8852 Fax: 884-8873 Ref: Mr N Vermaak AND TO: ___________________________ RESPONDENTS' ATTORNEY The State Attorney 4th Floor South Fedlife Forum Tower Van der Walt Street Pretoria Tel: (012) 310-2704 Fax: (012) 322-0177 Ref: Ms Behardien